Issues in Selection of Deltas in Non-Inferiority Trials : Acute Bacterial Meningitis and Hospital-Acquired Pneumonia

2/25/02


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Table of Contents

Issues in Selection of Deltas in Non-Inferiority Trials : Acute Bacterial Meningitis and Hospital-Acquired Pneumonia

Introduction

Clinical Trials

Non-Inferiority Trials

Non-Inferiority Margins

Components of Delta

Components of Delta - Delta 1

Components of Delta - Delta 2

Components of Delta - various diseases

Components of Delta Meningitis and HAP

Components of Delta Meningitis and HAP

Historical Data - Meningitis

Historical Data - Meningitis

Historical Data - HAP

Historical Data - HAP

Historical Data - HAP

Components of Delta Meningitis

Components of Delta HAP

Components of Delta Meningitis and HAP

Consequences of Failure

Practical Issues

Clinical Trial Implications: Sample size per arm to achieve 80% power

Epidemiology of Meningitis*

Epidemiology of Meningitis

Epidemiology of HAP

Epidemiology

Recent Trials

Clinical Trial Implications: Sample size per arm to achieve 80% power

Components of Delta Meningitis and HAP

The Balance

Author: Infectious Diseases